CN218607704U - Balloon dilatation catheter - Google Patents

Abstract

The application relates to the technical field of medical equipment, provides a sacculus expansion pipe, includes: the side wall of the outer pipe is provided with a side hole; the balloon body is arranged at the end part of the outer tube and communicated with the outer tube; the inner tube is worn to establish in proper order the outer tube reaches ball utricule and outwards extend, the inner tube is including first connecting portion, main part and the second connecting portion that communicate in proper order, first connecting portion are kept away from the one end of main part with the side opening is linked together, the second connecting portion are kept away from the one end of main part weld in the ball utricule, the internal diameter of main part is 0.0175 inch ~ 0.0185 inch. Above-mentioned sacculus expansion pipe can reduce the resistance that the guide wire removed in the use, makes things convenient for medical personnel's operation, does benefit to through narrow pathological change department, improves trafficability characteristic to it is big to solve the resistance that current sacculus expansion pipe guide wire removed in the use, trafficability characteristic deviation's technical problem.

Description

Balloon dilatation catheter

Technical Field

The application relates to the technical field of medical equipment, in particular to a balloon dilatation catheter.

Background

With the aging of the population in China, the incidence rate of atherosclerosis is higher and higher, and the operation amount is increased year by year. In the clinical operation process, doctors can diagnose and treat through interventional therapy operations, and the interventional therapy operations (artery balloon dilatation operations and stent implantation operations) are diagnosis and treatment operations performed by adopting a series of interventional instruments and materials and modern digital diagnosis and treatment equipment. Compared with the traditional surgical operation, the interventional therapy has the advantages of less bleeding, less wound, less complication, quick postoperative recovery, safety, reliability and the like, and can greatly relieve the pain born by the patient. In addition, balloon dilation catheter treatment is reproducible. When restenosis occurs, it can also be re-dilated by a minimally invasive procedure. In addition, even if the surgery fails, it has no significant effect on further stent or vascular bypass surgery. Therefore, the interventional treatment operation is gradually the first choice for treating arterial stenosis due to its advantages of minimal invasion, repeatable operation, good therapeutic effect, etc.

However, the conventional balloon dilatation catheter has trafficability deviation in the use process, particularly when encountering a stenotic part of a blood vessel, the balloon dilatation catheter needs to be matched with a guide wire for use, and the guide wire has large resistance during movement and product propulsion, so that the balloon dilatation catheter is difficult to smoothly pass through a lesion point, the operation difficulty of a doctor is increased, and the life safety of a patient can be endangered to a certain extent.

SUMMERY OF THE UTILITY MODEL

The application aims to provide a balloon dilatation catheter to solve the technical problems that the existing balloon dilatation catheter is large in resistance and prone to passing deviation when guiding a guide wire to move in the using process.

The embodiment of the present application provides a balloon dilatation catheter, including:

the side wall of the outer tube is provided with a side hole;

the balloon body is arranged at the end part of the outer tube and communicated with the outer tube;

the inner tube is worn to establish in proper order the outer tube reaches ball utricule and outwards extend, the inner tube is including first connecting portion, main part and the second connecting portion that communicate in proper order, first connecting portion are kept away from the one end of main part with the side opening is linked together, the second connecting portion are kept away from the one end of main part weld in the ball utricule, the internal diameter of main part is 0.0175 inch ~ 0.0185 inch.

In one embodiment, the first connecting portion has an inner diameter of 0.016-0.018 inches at an end away from the main body, and the second connecting portion has an inner diameter of 0.0145-0.0155 inches at an end away from the main body.

In one embodiment, the body has an outer diameter of 0.022 inches to 0.024 inches.

In one embodiment, the inner diameter of the main body is 0.018 inches, the outer diameter of the main body is 0.023 inches, the inner diameter of the second connecting portion at the end away from the main body is 0.015 inches, and the inner diameter of the first connecting portion at the end away from the main body is 0.017 inches.

In one embodiment, the second connecting portion has a tapered structure, and an inner diameter of the second connecting portion toward the end of the main body is larger than an inner diameter of the second connecting portion away from the end of the main body.

In an embodiment, the first connecting portion is welded to a sidewall of the outer tube to form the side hole, and the side hole has a predetermined inclination angle with an axis of the main body.

In one embodiment, the inner tube is a multi-layer composite plastic tube.

In one embodiment, the inner pipe comprises an inner layer, a middle layer and an outer layer which are sequentially stacked, the inner layer is made of high-density polyethylene, the middle layer is made of linear low-density polyethylene, and the outer layer is made of nylon 11 or nylon 12.

In one embodiment, the inner tube is provided with a developing ring, and the developing ring is positioned in the balloon body.

In one embodiment, the balloon dilatation catheter further comprises a hypotube and a catheter hub connected, and one end of the outer tube, which is far away from the balloon body, is welded to the hypotube.

The utility model provides a sacculus expansion pipe, including outer tube, sacculus and inner tube, outer tube and sacculus body are worn to establish in proper order and extend outwards to the inner tube, and then the inner tube can provide a relatively stable inner chamber for the guide wire to pass, because the internal diameter of main part keeps unanimous, reducible shape excessively changes and leads to the guide wire to remove the condition that is not smooth and easy. In addition, on the premise of ensuring that the outer diameter of the whole balloon dilatation catheter is not changed and the trafficability characteristic is not influenced, the inner diameter of the main body is 0.0175-0.0185 inches which is larger than the inner diameter of the existing inner tube, namely, the guide wire cavity is enlarged, the resistance of the balloon dilatation catheter and the guide wire in matching use is reduced, and the resistance of the guide wire in moving is reduced. After entering human blood vessel, the resistance reduction that the guide wire removed can make things convenient for medical personnel's operation, does benefit to through narrow pathological change department, improves the trafficability characteristic to it is big effectively to solve the resistance that current sacculus expansion pipe guide wire removed in the use, trafficability characteristic deviation's technical problem.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive exercise.

FIG. 1 is a schematic structural view of a balloon dilation catheter provided in accordance with an embodiment of the present application;

FIG. 2 is an enlarged partial schematic view of the structure shown in A of FIG. 1;

FIG. 3 is an enlarged partial schematic view of the structure shown in B of FIG. 1;

FIG. 4 is a cross-sectional view taken along line L-L of the balloon dilation catheter shown in FIG. 1;

FIG. 5 is a schematic view of the inner tube and balloon body of the balloon dilation catheter of FIG. 1;

FIG. 6 is an enlarged partial schematic view of the structure shown in C of FIG. 5;

fig. 7 is a schematic structural diagram of an assembly according to an embodiment of the present application.

The designations in the figures mean:

100. a balloon dilation catheter;

10. an outer tube; 11. a side hole; 12. a fluid chamber;

20. a balloon body;

30. an inner tube; 31. a first connection portion; 32. a main body; 33. a second connecting portion; 34. a guidewire lumen; 35. a developing ring;

40. a mandrel;

50. an assembly;

60. a hypotube;

70. a catheter hub.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more clearly understood, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "inner," "outer," and the like are used herein to indicate an orientation or positional relationship based on that shown in the drawings for ease of description and simplicity of description only, and do not indicate or imply that the device or element so referred to must be oriented, constructed or operated in a particular orientation, and therefore should not be construed as limiting the application. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can include, for example, fixed connections, removable connections, or integral parts; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as the case may be.

In order to explain the technical solutions described in the present application, the following description is made with reference to specific drawings and examples.

The embodiment of the application provides a sacculus expansion pipe, can be used to the coronary artery and intervene the operation, through the wire guide chamber of improvement sacculus expansion pipe, can reduce the resistance that the guide wire removed to a certain extent to improve in the use, the mobility of guide wire in the wire guide chamber of sacculus expansion pipe helps medical personnel to pass the narrow pathological change department with the product more smoothly.

Referring to fig. 1 to 5, in one embodiment of the present application, a balloon dilation catheter 100 includes an outer tube 10, a balloon body 20, and an inner tube 30.

A side hole 11 for guiding a guide wire to penetrate is formed on the side wall of the outer tube 10.

The balloon body 20 is provided at an end of the outer tube 10 and communicates with the outer tube 10. It is understood that a containing cavity is provided in the balloon body 20, and gas or liquid can be delivered into the containing cavity through the outer tube 10 to achieve the inflation of the balloon body 20.

The inner tube 30 sequentially penetrates through the outer tube 10 and the balloon body 20 and extends outwards, the inner tube 30 comprises a first connecting portion 31, a main body 32 and a second connecting portion 33 which are sequentially communicated, one end, far away from the main body 32, of the first connecting portion 31 is communicated with the side hole 11, one end, far away from the main body 32, of the second connecting portion 33 is welded to the balloon body 20, and the inner diameter of the main body 32 is 0.0175-0.0185 inches. The inner diameter of the main body 32 is kept consistent, and the condition that the guide wire moves unsmoothly due to excessive shape change is reduced.

The inner tube 30 is provided therein with a guide wire lumen 34 for placing a guide wire, the side hole 11 is a guide wire inlet a, one end of the inner tube 30 away from the side hole 11 is a guide wire outlet b, i.e., the guide wire inlet a is disposed on the first connecting portion 31, and the guide wire outlet b is disposed on the second connecting portion 33, so that the guide wire can enter the guide wire lumen 34 of the inner tube 30 from the side hole 11 on the side wall of the outer tube 10, and extend outward after penetrating through one end of the inner tube 30 away from the side hole 11 via the guide wire lumen 34.

The current standard guide wire used in clinic has a diameter of 0.014 inch and a length of 180 cm-190 cm. Second, the inner tube 30, which is currently used in clinical practice, has an inner diameter of 0.0165 inches and an outer diameter of 0.0215 inches, and the guidewire lumen 34 has a small diameter, which causes a large resistance to the movement of the guidewire in the inner tube 30.

The balloon dilatation catheter 100 provided by the present application comprises an outer tube 10, a balloon body 20 and an inner tube 30, wherein the inner tube 30 sequentially penetrates through the outer tube 10 and the balloon body 20 and extends outwards, and the inner tube 30 can provide a relatively stable inner cavity for a guide wire to pass through, and the inner diameter of the main body 32 is kept consistent, so that the situation of unsmooth movement of the guide wire caused by excessive shape change can be reduced. In addition, on the premise of ensuring that the outer diameter of the whole balloon dilatation catheter 100 is unchanged and the passing performance is not affected, the inner diameter of the main body 32 is 0.0175-0.0185 inches, which is larger than the inner diameter of the existing inner tube 30, and is equivalent to enlarging the guide wire cavity 34, so that the resistance of the balloon dilatation catheter 100 in cooperation with the guide wire is reduced, and the resistance of the guide wire in moving is reduced. After entering human blood vessel, the resistance reduction that the guide wire removed can make things convenient for medical personnel's operation, does benefit to through narrow pathological change department, improves the trafficability characteristic to it is big effectively to solve the resistance that current sacculus expansion pipe guide wire removed in the use, trafficability characteristic deviation's technical problem.

It will be appreciated that the end of the second connecting portion 33 remote from the main body 32 should avoid an oversize inner diameter to avoid affecting the pushing of the guide wire.

In one embodiment of the present application, the first connecting portion 31 has an inner diameter of 0.016 to 0.018 inches at an end away from the main body 32, and the second connecting portion 33 has an inner diameter of 0.0145 to 0.0155 inches at an end away from the main body 32. The first connection portion 31 and the second connection portion 33 are both reducer pipes, and are respectively connected with the main body 32 in an arc transition manner to reduce the frictional resistance of the guide wire in the guide wire cavity 34, so that the inner diameter of the inner tube 30 is in a range of 0.0145 inches to 0.0185 inches.

Wherein, the inner diameter of the welding point at the far end, namely the exit b of the guide wire, which is commonly used in clinic at present is 0.014 inch; the inner diameter at the guidewire entrance a is also 0.014 inches, providing greater resistance to the guidewire passing into the inner tube 30 and out of the inner tube 30. According to the balloon dilatation catheter 100 provided by the application, on the premise that the outer diameter of the whole balloon dilatation catheter 100 is unchanged and the passability is not affected, one end, away from the main body 32, of the first connecting part 31 can be used for guiding a guide wire to enter, and the inner diameter is 0.016-0.018 inches and is larger than that of the existing guide wire inlet a; secondly, one end of the second connecting part 33 far away from the main body 32 can be used for leading out the guide wire, and the inner diameter is 0.0145-0.0155 inches which is larger than the inner diameter of the existing guide wire outlet b, thereby enlarging the space of the guide wire cavity 34 of the inner tube 30 and reducing the resistance of the guide wire to move.

In one embodiment of the present application, the outer diameter of the body 32 is between 0.022 inches and 0.024 inches. The conventional inner tube 30 has an outer diameter of 0.0215 inches, and since the inner diameter of the inner tube 30 is properly increased in the present application, the outer diameter of the main body 32 should be properly increased in order to maintain the mechanical properties of a certain wall thickness. It can be understood that the outer diameters of the first connecting portion 31 and the second connecting portion 33 should be increased as compared to the two ends of the conventional inner tube 30.

In this embodiment, the inner diameter of the main body 32 is 0.018 inch, the outer diameter of the main body 32 is 0.023 inch, the inner diameter of the end of the second connecting portion 33 away from the main body 32 is 0.015 inch, and the inner diameter of the end of the first connecting portion 31 away from the main body 32 is 0.017 inch. In this way, the entire guide wire lumen 34 of the inner tube 30 of the balloon dilatation catheter 100 is enlarged, and the movement resistance of the guide wire is reduced.

It is understood that, in other embodiments of the present application, the inner diameter of the main body 32, the outer diameter of the main body 32, and the inner diameter of the end of the second connecting portion 33 away from the main body 32 may also be any other value within the corresponding range, and are not limited herein.

Referring to fig. 1, 2 and 5, in an embodiment of the present application, the second connecting portion 33 has a tapered structure, and an inner diameter of an end of the second connecting portion 33 facing the main body 32 is larger than an inner diameter of an end of the second connecting portion 33 away from the main body 32. In this way, the second connection portion 33 is designed to have a tapered outer diameter as a whole, so that the resistance to the advancement of the balloon catheter 100 in the blood vessel can be reduced, the head of the balloon catheter 100 can be advanced in a tortuous blood vessel, and the trackability of the balloon body 20 with respect to the guide wire can be ensured.

The second connection portion 33 and the balloon body 20 are fixed by welding, and specifically, after the inner tube 30 is inserted into the core shaft 40 with a preset diameter to form the assembly 50, the assembly 50 is inserted into the outer tube 10 and welded at the second connection portion 33. After the welding is finished, the mandrel 40 is pulled out, and the guide wire outlet b with the preset inner diameter can be obtained.

In one embodiment of the present application, the first connection portion 31 is welded to the sidewall of the outer tube 10 to form the side hole 11, and the side hole 11 has a predetermined inclination angle with respect to the axis of the main body 32. Thus, the guide wire can be inserted into the side hole 11 at an oblique angle, so that the friction between the guide wire and the inner wall of the first connecting portion 31 is reduced, and the movement resistance of the guide wire is reduced, thereby preventing a large friction between the guide wire and the inner wall of the inner tube 30 due to vertical insertion.

In the present embodiment, referring to fig. 3 and 5, the side hole 11 is generally oval, and the length thereof along the axial direction parallel to the main body 32 is 2mm to 4mm. It can be understood that the first connection portion 31 is connected with the main body 32 in a smooth transition manner, so as to facilitate the movement of the guide wire in the guide wire cavity 34 and improve the passing performance of the guide wire. Secondly, after the first connecting part 31 is welded on the side wall of the outer tube 10 to form the side hole 11, the cutting is also needed, so that the side hole 11 is cut in a smooth inclined plane, a step-type structure is not formed, the balloon dilatation catheter 100 can move in a blood vessel, and the withdrawal resistance is reduced; in addition, the balloon dilatation catheter 100 can avoid the step structure from scratching the blood vessel when being withdrawn.

In one embodiment of the present application, the inner tube 30 is a multi-layered composite plastic tube. Thus, the bending resistance, hardness, force transmission effect, pushing performance and other performances of the inner pipe 30 can be improved through the compounding of multiple layers of materials.

Specifically, in the present embodiment, the inner tube 30 includes an inner layer, an intermediate layer, and an outer layer, which are sequentially stacked. The inner layer is made of high-density polyethylene (HDPE) material, has good wear resistance and smoothness, and has a smooth surface, so that friction between the inner layer and the guide wire can be reduced; the middle layer is made of Linear Low Density Polyethylene (LLDPE) material, and has good flexibility and elongation; the outer layer is made of nylon 11 or nylon 12 materials, and compared with the traditional block polyether amide (PEBAX) materials, the hardness is enhanced, so that a certain compression deformation amount is increased to resist the pressure given by fluid or gas in the outer tube 10 or the balloon body 20, the bending resistance of the balloon dilatation catheter 100 at a blood vessel bending part is enhanced, the strength and the hardness are high, the force transmission effect is good, and the pushing performance is better.

The optimization of the inner cavity after the combination of the three layers of materials ensures that the inner tube 30, the balloon body 20 and the outer tube 10 are welded firmly without affecting the overall trafficability, the propelling performance and the tracking performance of the balloon dilatation catheter 100, increases the inner space of the guide wire cavity 34 and reduces the resistance to the movement of the guide wire.

Referring to fig. 5-7, in one embodiment of the present application, the inner tube 30 is provided with a developing ring 35, and the developing ring 35 is located in the balloon body 20. So, accessible development ring 35 clearly images under the X ray environment in order to fix a position balloon 20, makes things convenient for the operator to adjust the shift position of balloon 20.

In this embodiment, there are two developing rings 35, which are alternately sleeved on the inner tube 30, but it should be understood that in other embodiments of the present application, the number and arrangement of the developing rings 35 may be other, and are not limited thereto.

Referring to fig. 1, 4 and 5, in one embodiment of the present application, the balloon dilation catheter 100 further includes a hypotube 60 and a catheter hub 70 connected, and an end of the outer tube 10 distal to the balloon 20 is welded to the hypotube 60. A complete balloon dilation catheter 100 is formed by balloon 20, outer tube 10, hypotube 60 and catheter hub 70 for interventional procedures.

It will be appreciated that, when assembled into a finished product, the balloon dilation catheter 100 has two catheter lumens, a fluid lumen 12 within the outer tube 10 for pressurizing the balloon body 20, the fluid lumen 12 communicating with the receiving lumen, and a guidewire lumen 34 for guiding a guidewire within the inner tube 30.

In one embodiment of the present application, the inner tube 30 of the balloon dilation catheter 100 is fixedly connected to the balloon body 20 and the outer tube 10 mainly by welding, and constitutes the guide wire lumen 34. Specifically, the method comprises the following two steps:

first, the distal end is welded.

The distal end refers to the end where the balloon body 20 is located and the proximal end refers to the end where the hub 70 is located. First, a mandrel 40 having a diameter of 0.015 inches is used to penetrate into the guidewire lumen 34 of the inner tube 30 having an inner diameter of 0.018 inches and an outer diameter of 0.023 inches; then, after the pressing and developing, the assembly 50 is formed, and then the assembly 50 is inserted into the fluid cavity 12 of the outer tube 10, and the inner tube 30 of the assembly 50 and the balloon body 20 are spliced in place for distal welding. After the weld is completed, the mandrel 40 is pulled out of the 0.015 inch diameter, at which time a portion of the wire guide lumen 34, i.e., the inner lumen of the weld, is 0.015 inch, and the diameter of the exit of the wire guide lumen 34 is enlarged relative to commercially available products. The point of the distal end welding is the exit of the guide wire, and the distal end welding is completed.

Next, the side hole 11 is welded.

A 0.017 inch diameter mandrel 40 is used to pass through an inner tube 30 having an inner diameter of 0.018 inch and an outer diameter of 0.023 inch and then welded to the outer tube 10 comprising the fluid lumen 12. After the welding is completed, the mandrel 40 having a diameter of 0.017 inch is pulled out to form the side hole 11, in which the inner diameter of the side hole 11 is 0.017 inch, and this side hole 11 is the guide wire inlet a. The diameter at the entrance to the guidewire lumen 34 is enlarged relative to commercially available products. The point of the proximal end welding is the entrance of the guide wire, and the side port welding is finished.

Through the two welding steps described above, the guidewire lumen 34 is formed within the fluid lumen 12, and the overall inner diameter of the guidewire lumen 34 is enlarged.

The above-mentioned embodiments are only used for illustrating the technical solutions of the present application, and not for limiting the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; such modifications and substitutions do not substantially depart from the spirit and scope of the embodiments of the present application and are intended to be included within the scope of the present application.

Claims (10)

1. A balloon dilation catheter, comprising:

the side wall of the outer pipe is provided with a side hole;

the balloon body is arranged at the end part of the outer tube and communicated with the outer tube;

the inner tube is worn to establish in proper order the outer tube reaches ball utricule and outwards extend, the inner tube is including first connecting portion, main part and the second connecting portion that communicate in proper order, first connecting portion are kept away from the one end of main part with the side opening is linked together, the second connecting portion are kept away from the one end of main part weld in the ball utricule, the internal diameter of main part is 0.0175 inch ~ 0.0185 inch.

2. The balloon dilation catheter of claim 1 wherein the first connector portion has an inner diameter of between 0.016 inches and 0.018 inches at an end distal from the main body, and the second connector portion has an inner diameter of between 0.0145 inches and 0.0155 inches at an end distal from the main body.

3. The balloon dilation catheter according to claim 2 wherein the outer diameter of the body is between 0.022 inches and 0.024 inches.

4. The balloon dilation catheter of claim 3 wherein the inner diameter of the body is 0.018 inches, the outer diameter of the body is 0.023 inches, the inner diameter of the second connector at the end distal from the body is 0.015 inches, and the inner diameter of the first connector at the end distal from the body is 0.017 inches.

5. The balloon dilation catheter according to claim 1 wherein the second connecting portion is of a tapered configuration and has an inner diameter towards the end of the body that is greater than an inner diameter of the second connecting portion away from the end of the body.

6. The balloon dilation catheter according to claim 1, wherein the first connection portion is welded to a side wall of the outer tube to form the side hole, the side hole having a preset angle of inclination to an axis of the main body.

7. The balloon dilation catheter according to claim 1 wherein the inner tube is a multi-layered composite plastic tube.

8. The balloon dilation catheter according to claim 7, wherein the inner tube comprises an inner layer, a middle layer and an outer layer which are sequentially stacked, the inner layer is made of high density polyethylene, the middle layer is made of linear low density polyethylene, and the outer layer is made of nylon 11 or nylon 12.

9. The balloon dilatation catheter of claim 1 wherein the inner tube has a visualization ring on it, the visualization ring being located inside the balloon body.

10. A balloon dilation catheter according to any one of claims 1 to 9 further comprising a hypotube and a catheter hub connected, an end of the outer tube remote from the balloon being welded to the hypotube.

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